Method and System for Closing Left Atrial Appendage

ABSTRACT

The present teachings provide methods for resizing, reducing, and closing left atrial appendage. Specifically, a percutaneous trans-septal access is first established from outside the body to a patient&#39;s LAA. At least two tissue anchors are then implanted inside the LAA chamber and along the tissue wall. At least one anchor is implanted near the opening of the LAA camber. Both tissue anchors are pulled together so that the wall of the LAA chamber collapse. The LAA chamber is therefore resized, reduced, and/or closed off completely. This closure method and system could be used alone in closing LAA chamber. This closure method and system could also be used in addition to other treatment mechanisms, such as filling the LAA chamber with space-filling material, then closing off its opening.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application is based on and claims priority to U.S. ProvisionalPatent Application 62/342,187, filed May 26, 2016, the entire contentsof which is incorporated by reference herein as if expressly set forthin its respective entirety herein.

TECHNICAL FIELD

The present teachings generally relate to a treatment system and its usein reshaping, reducing, and closing the left atrial appendage.

BACKGROUND

The left atrial appendage (LAA) is a muscular pouch connected to theleft atrium of a heart. Since the LAA lies within the confines of thepericardium and in close relation to the free wall of the leftventricle, its emptying and filling may be significantly affected byleft ventricular function.

When patients have a normal heart rhythm, the atrial appendage squeezesrhythmically with the rest of the left atrium. In doing so, all of theblood in LAA is ejected into the left atrium and distributed all overthe body, including the muscles, the organs, and the brain, with therest of the blood from that chamber.

Atrial fibrillation is a common rhythm disturbance in older patients, inwhich the top chambers of the heart do not beat regularly. In afibrillating atrium, the LAA becomes a major site of blood stasis, whichsignificantly increases the risk of clot formation. Indeed, almost 15%of all patients with nonvalvular atrial fibrillation (NVAF) developthrombus in their heart. For those who are at the highest risk forthromboembolic events, anticoagulation, including warfarin and the neweranticoagulants, has been offered. However, this is a difficultmedication and patient compliance can be difficult. Dietary restrictionsare necessary, the dose of the medication may need to be changedfrequently, and blood testing is required at least once a month. Inaddition, anticoagulation increases the risk of both intracerebral andextracranial bleeding.

Approximately 30% to 50% of patients with atrial fibrillation are noteven eligible to receive anticoagulation. In the recent years, severalpercutaneous LAA occlusion devices have been developed. The PercutaneousLeft Atrial Appendage Transcatheter Occlusion (PLAATO) device (ApprivaMedical) was the first to be tested and used in humans. Since then,multiple devices have emerged, including the Amplatzer device (AGAMedical Corporation/St. Jude Medical), the Watchman device (BostonScientific), the WaveCrest device (Coherex), LAA occluder (Occlutech),and LAmbre device (Lifetech). A common characteristic of these devicesis a relative large metal cage designed to self-expand and lodge intothe LAA. It has been reported that a significant learning curve existsfor physicians to adopt these treatments. Device-related embolizationduring or after the procedure and erosion of the device into the tissueare constant concerns for these implants

LARIAT suture delivery device (SentreHeart) differs from all the aboveimplant devices —only a suture is used to tie-up the LAA. The LARIATdevice is deployed by a trans-pericardial approach, specifically, byusing an epicardial snare with a pre-tied suture to lasso and occludethe LAA. Both the intracardiac trans-septal access to the LAA and directpericardial access are required. There are many access-relatedcomplications associated with the LARIAT device, including seriouspericardial effusion and major bleeding.

Surgical techniques to occlude the LAA also continue to evolve, withefforts being made to overcome the inconsistent closure, tissue tearing,and intrathoracic bleeding associated with suturing or staplingtechniques. For example, a widely used device, the AtriClip® (Atricure),consisting of a parallel titanium crossbar clip covered with wovenpolyester fabric, has received a CE Mark and is approved by the FDA forthe closure of the LAA under direct visualization in conjunction withother open cardiac surgical procedures.

Thus, drawbacks in each existing LAA closure device/method continue todemand improvement on the LAA closure technology, such as an effectiveclosure without post-procedure complications, minimum use of metal inthe implant, and minimum invasion approaches with less recovery time.

SUMMARY

One aspect of the present teachings provides a method for resizing a LAAchamber. The method comprises inserting a locating wire from the rightatrium, across the atrial septum, across the left atrium, and into theLAA chamber. The method further comprises placing the locating wireacross a tissue wall at a first location inside the LAA chamber andimplanting a first tissue anchor at the first location. The methodfurther comprises placing the locating wire across a tissue wall at asecond location inside the LAA chamber, and implanting a second tissueanchor at the second location. By pulling the first and second tissueanchors toward each other, the tissue walls at the first and secondlocations of the LAA chamber are pulled together.

Another aspect of the present teachings provides a method for resizing aLAA chamber. The method comprises inserting a locating wire from theright atrium, across the atrial septum, across the left atrium, and intothe LAA chamber. The method further comprises placing the locating wireacross a tissue wall at a first location inside the LAA chamber, andimplanting a first tissue anchor at the first location. The methodfurther comprises placing the locating wire across the tissue wall at asecond location inside the LAA chamber, and implanting a second tissueanchor at the second location. The method further comprises placing thelocating wire across the tissue wall approximate to a bottom of the LAAchamber, and implanting a third tissue anchor at the third location. Bypulling the first, second, and third tissue anchors toward one another,the bottom of the LAA chamber is everted, and the tissue walls at thefirst, second, and third locations of the LAA chamber are pulledtogether.

Another aspect of the present teachings provides a method for resizing aLAA chamber. The method comprises implanting a first tissue anchor at afirst location across a tissue wall inside a LAA chamber. The methodfurther comprises implanting a second tissue anchor at a second locationacross a tissue wall inside the LAA chamber. In one embodiment, thefirst tissue anchor is larger than the second tissue anchor. By pullingthe first and second tissue anchors toward each other, the LAA chambercollapses.

Another aspect of the present teachings provides a method for resizing aLAA chamber. The method comprises implanting a first tissue anchor at afirst location across a tissue wall inside a LAA chamber. The methodfurther comprises implanting a second tissue anchor at a second locationacross a tissue wall inside the LAA chamber. The method furthercomprises filling the LAA chamber with a space-filling material. Bypulling the first and second tissue anchors toward each other, thetissue walls at the first and second locations of the LAA chamber arepulled together, and the space-filling material is prevented fromescaping the LAA chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of the present teachingswhere a locating wire is positioned inside the right atrium according tothe present teachings.

FIG. 2 is a perspective view of an embodiment of the present teachingswhere a locating wire transeptally accesses the left atrium according tothe present teachings.

FIG. 3 is a perspective view of an embodiment of the present teachingswhere a distal end of a locating wire reaches the left atrial appendagein accordance with the present teachings.

FIG. 4 is a perspective view of an embodiment of the present teachingswhere a wire delivery catheter tracking along a locating wire and thedistal end of the wire delivery catheter reaches the left atrialappendage in accordance with the present teachings.

FIG. 5 is a perspective view of an embodiment of the present teachingswhere a locating wire pierces across the side tissue wall of the LAAcamber at a first location in accordance with the present teachings.

FIG. 6 is an embodiment of the tissue anchor in its delivery profileaccording to the present teachings.

FIGS. 7A-7C is an embodiment of the deployment of a first tissue anchoraccording to the present teachings.

FIG. 8 is a perspective view of an embodiment of the present teachingswhere the locating wire pierces across the side tissue wall of the LAAcamber at a second location in accordance with the present teachings.

FIGS. 9A-9C is an embodiment of the deployment of a second tissue anchoraccording to the present teachings.

FIG. 10 is a perspective view of an embodiment of the present teachingswhere the first and second tissue anchors are pulled together and lockedin place according to the present teachings.

FIG. 11A is another perspective view of an embodiment of the presentteachings where three tissue anchors are deployed at three differentlocations inside the LAA chamber according to the present teachings.

FIG. 11B is a perspective view of an embodiment of the present teachingswhere the three tissue anchors are pulled together and locked in placeaccording to the present teachings.

FIG. 12A is another perspective view of an embodiment of the presentteachings where two tissue anchors of different sizes are deployed attwo different locations inside the LAA chamber according to the presentteachings.

FIG. 12B is another perspective view of an embodiment of the presentteachings where the two tissue anchors are pulled together and locked inplace according to the present teachings.

FIG. 13 is another perspective view of an embodiment of the presentteachings where the LAA is filled with a space filling material and isclosed off with two exemplary tissue anchors according to the presentteachings.

FIG. 14 is another perspective view of an embodiment of the presentteachings where an exemplary closure plate is implanted inside the LAAchamber and the LAA is closed with two exemplary tissue anchorsaccording to the present teachings.

FIGS. 15A-15B are two exemplary embodiments of the deployed tissueanchor according to the present teaching.

FIGS. 16A-16C are another embodiment of the deployment of a plurality oftissue anchors joined by one tensioning member according to the presentteachings.

DETAILED DESCRIPTION

Certain specific details are set forth in the following description andfigures to provide an understanding of various embodiments of thepresent teachings. Those of ordinary skill in the relevant art wouldunderstand that they can practice other embodiments of the presentteachings without one or more of the details described herein. Thus, itis not the intention of the applicant(s) to restrict or in any way limitthe scope of the appended claims to such details. While variousprocesses are described with reference to steps and sequences in thefollowing disclosure, the steps and sequences of steps should not betaken as required to practice all embodiments of the present teachings.

As used herein, the term “lumen” means a canal, a duct, or a generallytubular space or cavity in the body of a subject, including a vein, anartery, a blood vessel, a capillary, an intestine, and the like. Theterm “lumen” can also refer to a tubular space in a catheter, a sheath,a hollow needle, a tube, or the like.

As used herein, the term “proximal” shall mean close to the operator(less into the body) and “distal” shall mean away from the operator(further into the body). In positioning a medical device inside apatient, “distal” refers to the direction relatively away from acatheter insertion location and “proximal” refers to the directionrelatively close to the insertion location.

As used herein, the term “wire” can be a strand, a cord, a fiber, ayarn, a filament, a cable, a thread, or the like, and these terms may beused interchangeably.

As used herein, the term “sheath” may also be described as a “catheter”and, thus, these terms can be used interchangeably.

Unless otherwise specified, all numbers expressing quantities,measurements, and other properties or parameters used in thespecification and claims are to be understood as being modified in allinstances by the term “about.” Accordingly, unless otherwise indicated,it should be understood that the numerical parameters set forth in thefollowing specification and appended claims are approximations. At thevery least and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the claims, numerical parametersshould be read in light of the number of reported significant digits andthe application of ordinary rounding techniques.

In one aspect, the present teachings relate to percutaneous treatmentmethods and systems that reduce the size of the LAA chamber (8) and/orclose off the opening of the LAA. In various embodiments, the treatmentsystem can also be used in conjunction with other LAA closure implantsand materials. A person with ordinary skill in the art would recognizethat the figures and description thereto refer to various embodiments ofthe present teachings and, unless indicated otherwise by their contexts,do not limit the scope of the attached claims.

An aspect of the present teachings relates to methods of creating apercutaneous access to the LAA via a transeptal approach. In variousembodiments, the method includes locating a first implantation sitealong the LAA chamber wall (18) with a tissue piercing wire. In variousembodiments, the first tissue anchor (20) is implanted at such location.In various embodiments, following the same methods, one or more than onetissue anchors (20) are then implanted at another or other locationsalong the LAA chamber wall (18). Once a clinician is satisfied with thesecure implantation of the multiple tissue anchors (20), in someembodiments, she/he would then pull all the anchors toward one another.As the tissue anchors (20) coming closer to each other, the side wall ofthe LAA chamber (8) is drawn radially inward. Another aspect of thepresent teachings includes using a lock to secure the tensioned positionof the tissue anchors (20), thereby completing the resizing and/orclosure of the LAA chamber (8).

In one aspect of the present teachings, where the tissue anchors(20) areimplanted near the opening of the LAA chamber (8), the opening of theLAA chamber (8) are closed off as the anchors are pulled together. Inanother aspect of the present teachings, where at least one tissueanchor (20) is implanted at the bottom of the LAA chamber (8) while theother anchors are implanted along the side wall of the LAA chamber (8),as the tissue anchors (20) are drawn toward one another, the bottom ofthe LAA chamber (8) is everted and the LAA chamber (8) is effectivelyeliminated.

In another aspect of the present teachings, a first tissue anchor (20)is implanted near the opening of the LAA chamber (8), and a secondtissue anchor (30) greater in size than the first tissue anchor (20) isimplanted opposite of the first anchor. As the two tissue anchors (20)are drawn toward each other, the LAA chamber wall (18) collapses. In oneembodiment, the second tissue anchor (30) has a bar shaped deployedprofile. In another embodiment, the second tissue has an expandedumbrella-shaped or plate-shaped deployed profile.

Another aspect of the present teachings provides a method for closing aLAA chamber (8) using the tissue anchor (20) system in combination withother treatment mechanisms. According to one embodiment, the LAA chamber(8) is first filled with a gel or other space filler, then closed withtissue anchors (20) as described herein.

In one aspect of the present teaching, at least one tissue anchor (20)is implanted along the LAA chamber wall (18) while within 2-4 mm to thejunction of the LAA and atrium chamber. In another embodiment, for theumbrella-shaped, or plate-shaped tissue anchor (80) has a generaldiameter of 15-30 mm.

According to some embodiments of the present teachings, the treatmentprocedure starts with establishing a percutaneous access to LAA. FIG. 1illustrates that a wire delivery catheter (10) assembly percutaneouslyreaches the right atrium (2). The wire delivery catheter (10) assemblyincludes a locating wire (12) and a wire delivery catheter (10). Thewire delivery catheter (10) has a proximal end, a distal end, and alongitudinal lumen extending from its proximal end to its distal end.The locating wire (12) is slidably disposed within the longitudinallumen of the wire delivery catheter (10). According to some embodiments,a distal portion of the wire delivery catheter (10) is configured to beable to articulate to various directions according to the anatomy inorder for its distal end to be positioned nominal to the tissue.

The locating wire (12) also has a proximal end, a distal end configuredfor tissue piercing, and an elongated body extending from the distal endto the proximal end. In some embodiments, the distal end of the locatingwire (12) has a sharpened profile for piercing through the heart tissue.In another embodiment, the distal end of the locating wire (12) isconfigured to connect to a RF energy source. In some embodiments, thelocating wire (12) has a relatively flexible distal portion so that onceinside the wire delivery catheter (10), the distal portion of thelocating wire (12) straightens and adopts the profile of the distalportion of the catheter; and once outside of the wire delivery catheter(10), the distal portion of the locating wire (12) deflects and avoidsaccidentally puncture the heart wall.

According to some embodiments, a wire delivery catheter (10) assemblyreaches the right atrium (2) of the heart via a standard right heartcatheterization, that is, through the femoral vein, the inferior venacava, and the right atrium (2). In various embodiments, the procedureincludes transseptally accessing the left atrium (6) via a septalpuncture.

Once the distal end of the wire delivery catheter (10) assembly isinside the right atrium (2), a distal end of the wire delivery catheter(10) extends further distally. As shown in FIG. 2, the distal end of thewire delivery catheter (10) presses against the atrial septum. Accordingto some embodiments, the distal end of the wire delivery catheter (10)positions against the fossa ovalis (4) and the wire (12) is thenadvanced distally to pierce the septum at the fossa ovalis (4). In oneembodiment, the wire is designed to have a sharp distal tip that isconfigured to pierce the septum. In another embodiment, suchtrans-septal puncture is accomplished with the assistant of aradiofrequency energy.

The present teachings as described herein provides an embodiment wherethe access across the heart tissue is established with the wire deliverycatheter (10) and the locating wire (12). In some embodiments, the wiredelivery catheter (10) and the locating wire (12) are combined toestablish the access across the heart tissue. In one embodiment, thedistal end of the wire delivery catheter (10) is pressed against theatrial septum and the locating wire (12) is held close to the tissuesurface. One skilled in the art should understand that such tissuepiercing procedure could be accomplished by the locating wire (12)acting alone, or in combination with other appropriate design. Theembodiments disclosed herein should not be viewed as limiting to thescope of the present teachings.

According to one embodiment of the present teachings, a guide catheter(14) tracks over the wire delivery catheter (10), crossing the atrialseptum. The guide catheter (14) remains across the septum with itsdistal end extending inside the left atrium (6) throughout the entireprocedure. In such way, an access path for all implants to be deployedand the delivery system carrying the implants are established. The guidecatheter (14) has an elongated body with an axial lumen extending from aproximal end to a distal end. The proximal end of the catheter (14)remains under the control of a clinician throughout the procedure.

Continue referring to FIG. 3, upon crossing the septum, the distal endof the wire delivery catheter (10) assembly extends distally toward LAA.According to some embodiments, the wire delivery catheter (10) assemblyis further used to mark the implantation location. As the wire deliverycatheter (10) assembly extends further distally, its distal end reachesinside the LAA chamber (8). Once the distal end of the wire deliverycatheter (10) is positioned inside the LAA chamber (8), the clinicianactuates the distal portion of the wire delivery catheter (10) so thatthe distal end faces the inner wall of the LAA chamber (8), for example,as shown in FIG. 4. The locating wire (12) then further advancesdistally with its distal tip piercing the side wall of the LAA chamber(8) and marking the first implantation location.

One skilled in the art should appreciate that the wire delivery catheter(10) disclosed herein may have distal portions that are steerable invarious manners for accurate positioning. For example, the distal endportion of the wire delivery catheter (10) is steerable into a desiredhockey-curve or hook-like position by a guiding cable embedded in theluminal wall of the catheter, which may be pulled to configure thedistal end portion of catheter into the hook-like shape as shown. Insome embodiments, a catheter utilized herein includes a unidirectionalor bi-directional steering mechanism. A steering mechanism may bepositioned within and/or on the device. Typically, the steeringmechanism may include a pull wire terminating at a flat spring or collarat the distal end of the wire delivery catheter (10). The steerablecatheter has a more flexible distal section compared to the proximalportion of the catheter body. When tension is placed on the pull wire,the distal end of the catheter deflects into a curved or bend shape,which in turn guides the locating wire (12) to face accurately towardthe tissue to be pierced at the intended location. The pull wire may bewound, crimped, spot welded, or soldered to the distal end of the wiredelivery catheter (10). This provides a stable point within the wiredelivery catheter (10) for the pull wire to exert a tensile force andsteer the distal portion of the catheter. The more proximal portion ofthe catheter may be reinforced by incorporating a helically wound orbraided wire therein to provide column support from which to betterdeflect the distal section.

Other steerable mechanisms should also work for the wire deliverycatheter (10) disclosed herein. For example, the steering mechanism mayconsist of a body with a relatively flexible distal portion and arelatively rigid proximal portion; and a superelastic steering wire thatis configured to slide in and out of a side lumen of the wire deliverycatheter (10). The superplastic steering wire is pre-programmed to havea desired three-dimensional geometric shape for atrial septal puncturingas well as LAA chamber wall (18) piercing at its distal portion.Extending the preformed steering wire into the relatively flexibledistal section of the wire delivery catheter (10) causes its distalsection to assume the shape of the steering wire. Retracting thepreformed steering wire proximally away from the relatively flexibledistal portion, and back into the relatively rigid proximal section ofthe wire delivery catheter (10), the distal portion of the wire deliverycatheter (10) straightens. Another example of the steerable catheterconstruct includes a pre-defined curve, for example, around 90°,preformed into the distal section, which allows the distal end of thewire delivery catheter (10) biases toward the tissue within anappropriate heart chamber. During a vascular delivery, such distalportion is then straightened by incorporating a tube or rod that can beadvanced through that section. One skilled in the art should recognizewhat has been described here should only be viewed as examples, and notto limit the scope of the present teachings.

According to some embodiments, the locating wire (12) is coupled with asuitable RF energy device (not shown) where the distal tip of thelocating wire (12) is configured to deliver radiofrequency (RF) energyto assist its crossing of the atrial septum, as well as the tissue wallof the LAA chamber (8). The distal tip of the locating wire (12) isdesigned to be atraumatic to prevent any inadvertent tissue damage. Oncethe distal tip is positioned approximately to the tissue to be pierced,the RF energy is activated to ablate the tissue within its range withoutcontacting the tissue. Once the distal tip of the locating wire (12)crosses through the tissue, the RF energy is then deactivated.Alternatively, the locating wire (12) can have a piercing tip whichallows it to perforate the atrial septum as well as the tissue wall ofthe LAA chamber (8). In such embodiments, the piercing tip is configuredto be hidden during the delivery and actuated when facing the tissue tobe crossed. The locating wire (12) can adopt many shapes and profilesfor the purpose of this application, including, for example, the RF wiredisclosed in U.S. patent application Ser. No. 14/138,926, filed on Feb.26, 2013, entitled “ENERGY ASSISTED TISSUE PIERCING DEVICE AND METHOD OFUSE THEREOF,” each of which is incorporated herein by reference in itsentirety. One skilled in the art should understand that other methodsand devices can also be used to assist the piercing or traversing of theheart tissue. Thus, the particular examples described herein should notbe viewed as limiting to the scope of the present teachings.

Now referring to FIG. 5, the distal end of the locating wire (12) isplaced across the LAA chamber wall (18) at a location within the LAAchamber (8) and near its opening, and a first tissue anchor is deployedat a location with the wire delivery catheter (10) removed out of theway. According to some embodiments, as illustrated in FIGS. 6-8, atissue anchor delivery catheter (22) tracks along the locating wire (12)and across the LAA chamber wall (18). In certain embodiments, the tissueanchor delivery catheter (22) is used to deliver a tissue anchor (20) tothe first implantation location inside the LAA chamber (8). In oneembodiment, the wire delivery catheter (10) withdraw proximally first,and the tissue anchor delivery catheter (22) tracks along the locatingwire (12), follows the delivery path maintained by the guide catheter(14), and reaches the first implantation location. One skilled in theart should understand that the tissue anchor delivery catheter (22)could track along the locating wire (12) by sliding over the proximalend of the locating wire (12), or alternatively the tissue anchordelivery catheter (22) could track along the locating wire (12) througha monorail fashion. Both embodiments should be viewed as within thescope of the present teachings.

FIGS. 7A-7C illustrate a first tissue anchor (20) deployed across animplantation site. One exemplary first tissue anchor (20) is shown inFIG. 6. According to some embodiments of the present teachings, theexemplary tissue anchor (20) includes an anchor element (26) and atensioning member (24). As shown in FIG. 6, the anchor element (26) hasa unitary configuration with a plurality of folded panels. The tissueanchor (26) is coupled to a tensioning member (24), in this example, asuture, by threading the suture distally through the anchor element (26)and proximally through the anchor element (26). A slip knot or anothertype of locking mechanism is formed so that when a proximal end portionof the tensioning member (24) is pulled, all of the anchor element (26)are drawn together to form a plurality of panels along the pre-setfolding lines. In addition, the pulling of a proximal end portion of thetensioning member (24), in some embodiments, draws the anchor element(26) at the distal end first and those at the proximal end next, asdiscussed elsewhere herein. Accordingly, in various embodiments, atissue anchor (20) of the present teachings has a delivery profile whereall panels are unfolded and elongated, and a deployed profile where allpanels are folded, preferably along the pre-set folding lines, therebyshortening its longitudinal profile. According to some embodiments, theanchor element (26) is made from a surgical grade fabric material (e.g.,a polyester material such as DACRON). In some embodiments, the anchorelement (26) is designed to promote tissue in-growth so that the anchorsbecome at least in part encased in tissues over-time.

Accordingly, in various embodiments, a tissue anchor (20) of the presentteachings includes an elongate or delivery configuration and a shortenedor deployed configuration. In some embodiments, in the deployedconfiguration, the anchor elements (26) are folded and is attached to along “tail” of the tensioning member (24), for example, a suture,leading from the anchor, for example, as shown in FIGS. 7A-7C. In someembodiments, the long “tail” can be used for attaching additional tissueanchors (20), tensioning, and plication, as described herein.

FIGS. 7A-7C illustrate an exemplary delivery and deployment of a firsttissue anchor (20) across the LAA chamber wall (18). FIG. 7A illustratesthe process of exposing the distal portion of the tissue anchor (20) andFIG. 7B illustrates the process of exposing the proximal portion of thetissue anchor (20). FIG. 7C illustrates an exemplary deployed tissueanchor (20) positioned at the location.

Once the locating wire (12) is placed at a first location across the LAAchamber wall (18), the wire delivery catheter (10) is withdrawnproximally from the body, leaving the wire to mark the spot. Referringto FIG. 7A, in some embodiments, a tissue anchor delivery catheter (22)holding a tissue anchor (20) inside its longitudinal lumen tracks alongthe locating wire (12) and crosses the LAA chamber wall (18). Continuingreferring to FIG. 7A, in some embodiments, the tissue anchor (20) ispartially pushed distally outside of the distal end of the tissue anchordelivery catheter (22). Once the distal portion of the tissue anchor(20) or a sufficient amount of the anchor element (26) is exposedoutside of the LAA chamber (8), a clinician can pull on the proximal endof the tensioning member (24) and cinch the exposed anchor element (26).The tissue anchor delivery catheter (22) is then retracted proximally sothat the distal end of the tissue anchor delivery catheter (22) movesproximally and back inside the LAA chamber (8). The clinician thenexposes the proximal portion of the tissue anchor (20) or the remainderof the anchor element (26) of the tissue anchor (20) within the rightatrium (2) by further retracting the tissue anchor delivery catheter(22) proximally as shown in FIG. 7B. As the clinician pulls the proximalend of the tensioning member (24), the proximal portion of the tissueanchor (20) element is cinched.

As illustrated in FIG. 7C, in various embodiments, as the clinicianpulls the proximal end of the tensioning member (24), the anchorelements (26) of the tissue anchor (20) are drawn together against theopposite sides of the LAA chamber (8), thereby securing the first tissueanchor (20) to the LAA chamber wall (18). As a result, as illustrated inFIG. 7C, in some embodiments, the first tissue anchor (20) is deployedacross the LAA chamber wall (18) near the LAA opening at the firstlocation with the distal portion of the tissue anchor (20) placedagainst the outside of the LAA chamber (8), the proximal portion of thetissue anchor (20) placed against the inside of the LAA chamber wall(18), and the tensioning member (24) of the first tissue anchor (20)extending proximally through the lumen of the tissue anchor deliverycatheter (22) to the outside of the body. According to some embodiments,the locating wire (12) that marks the first location and maintains thetissue access during the deployment of the first tissue anchor (20) iswithdrawn proximally after the distal portion of the tissue anchordelivery catheter (22) crosses the LAA chamber wall (18). In otherembodiments, the locating wire (12) that marks the first location andmaintains the annulus access during the deployment of the first tissueanchor (20) is withdrawn proximally after the entire tissue anchor (20)is deployed across the LAA chamber wall (18). According to someembodiments, upon withdrawn from the first implantation location, thedistal end of the locating wire (12) retracts back inside the tissueanchor delivery catheter (22). In another embodiment, as the locatingwire (12) retracts proximally from the first implantation location, itdisengages the tissue anchor delivery catheter (22), and the distal endof the locating wire (12) remains inside the left atrium (6) during thedeployment of the first tissue anchor (20). According to someembodiments, upon deployment of the tissue anchor (20) across the LAAchamber wall (18), the proximal end of the tensioning member (24) iscontrolled by the clinician from outside of the body.

FIGS. 6-7C are only one embodiment of the possible tissue anchor (20) tobe implanted across the tissue. Many other shapes and profiles could beadopted for the purpose of this application, including, for example, theannulus anchors disclosed in U.S. Pat. No. 8,951,285, filed on Jul. 5,2005, entitled “Tissue anchor and Anchoring System;” U.S. Pat. No.8,951,286, filed on Nov. 19, 2008, entitled “Tissue anchor, AnchoringSystem and Methods of Using the Same;” U.S. patent application Ser. No.14/581,264, filed on Dec. 23, 2014, entitled “Tissue anchor andAnchoring System;” U.S. Pat. No. 9,259,218, filed on Feb. 26, 2013,entitled “Tissue anchor and Anchoring System;” and U.S. Pat. No.8,945,211, filed on Sep. 11, 2009, entitled “TISSUE PLICATION DEVICE ANDMETHOD OF ITS USE;” each of which is incorporated herein by reference inits entirety. One skilled in the art should also understand thatexamples of suitable tissue anchors include, but not be limited to,tissue fasteners, tissue pledgets, or tissue staples etc.

With the first tissue anchor (20) securely deployed at the firstlocation across the LAA chamber wall (18), the clinician can deploy asecond tissue anchor (30) at a second location according to someembodiments of the present teachings. FIGS. 8-9C illustrate an exemplarydeployment of a second tissue anchor (30) at a second location acrossthe LAA chamber (8).

According to some embodiments, similar to what is described herein, forexample, in FIGS. 7A-7C, a clinician uses the similar steps to positionthe wire delivery catheter (10) against the LAA chamber wall (18) frominside the LAA chamber (8) at a second location. According to someembodiments, once the first tissue anchor (20) is securely deployed, thetissue anchor delivery catheter (22) is withdrawn from the body, leavinga tensioning member (24) with one end connecting to the tissue anchor(20) and the other end outside of the body and remaining under thecontrol of the clinician. A clinician extends the wire delivery catheter(10) sliding over the location wire that remains inside the left atrium(6) until the distal end of the wire delivery assembly enters the LAAchamber (8) and remains in place. The distal end of the wire deliverycatheter (10) is placed against the LAA chamber wall (18) by usingsimilar methods described herein or known to those with ordinary skillin the art.

Similar to what is described herein in accordance with FIGS. 7A-7C, oneend of the locating wire (12) is advanced across the LAA chamber wall(18) as illustrated in FIG. 8. As illustrated in FIG. 8, it results inthat the locating wire (12) is placed at the second location with thedistal end of the wire outside of the LAA chamber (8).

In various embodiments, a second tissue anchor (30) is deployed at thesecond location according to various embodiments described herein and asshown in FIGS. 9A-9C. FIGS. 9A-9C illustrate the embodiments where thesecond tissue anchor (30) is deployed across the LAA chamber (8) at thesecond location with the distal portion of the second tissue anchor (30)placed against the outside of the LAA, the proximal portion of thetissue anchor (30) placed against the inner LAA chamber wall (18), andthe tensioning member (34) of the second tissue anchor (30) extendingproximally through the trans-septal access to the outside of the body.Similar to what have been described above, during the deployment of thesecond tissue anchor (30), the locating wire (12) is withdrawnproximally with the distal end of the locating wire (12) eitherremaining inside the tissue anchor delivery catheter (22) or disengagingthe tissue anchor delivery catheter (22) and remaining inside the leftatrium (6).

As illustrated in FIG. 9C, two tissue anchors (20, 30) are implantedacross the LAA chamber wall (18) near the opening. According to someembodiments, such as shown in FIG. 9C, each tensioning member (24, 34)connects a tissue anchor (20, 30), and the two tissue anchors (20, 30)are spaced apart along the circumference of the LAA chamber (8).According to some embodiments of the present teachings, two tissueanchors (20, 30) are sufficient for closing the opening of the LAA. Yetin other embodiments, more than two tissue anchors are needed tocompletely close a LAA opening. One skilled in the art should understandthat the number of tissue anchors needed for closing a LAA chamber (8)should be decided by a clinician and based on each patient's anatomy andtreatment plan. Exemplary embodiments shown and described herein shouldnot be viewed as limiting to the scope of the present teaching.

Once a sufficient number of tissue anchors are implanted along the LAAchamber wall (18), the tissue anchor delivery catheter (22) and thelocating wire (12) can be removed from the body entirely. And a lockdelivery assembly with a lock delivery catheter and a locker (38) can beextended distally through the access path maintained by the guidecatheter (14), track over the tensioning member (24), and reach insidethe LAA chamber (8).

FIG. 10 illustrates an exemplary closure of the opening of the LAAchamber (8). In various embodiments, the closure is achieved by applyingtension to the two or more tissue anchors (20). In various embodiments,a clinician applies tension to the proximal end of the tensioningmembers (24). In some embodiments, this tension pulls the plurality oftissue anchors (20) closer to one another, thereby pulling the LAAchamber walls (18) toward one another and closing the opening. In someembodiments, this tension and the reduction of the circumference of theLAA are maintained, for example, by a locker or other locking mechanismsas shown in FIG. 10.

Suitable lockers include those well known in the art and those describedin U.S. application Ser. No. 11/753,921, filed on May 25, 2007, entitled“Lockers for Surgical Tensile Members and Methods of Using the Same toSecure Surgical Tensile Members,” the disclosure of which isincorporated herein by reference. With the tensioning members secured bya locker (not shown), the excess tensioning member proximal to thelocker can be removed by a cutter, including, for example, a cutterdisclosed in U.S. Pat. No. 8,911,461, filed on Nov. 5, 2007, entitled“Suture Cutter and Method of Cutting Suture,” the disclosure of which isincorporated herein by reference.

According to some embodiments of the present teachings, such as shown inFIG. 10, two similar tissue anchors are implanted inside and across theLAA chamber wall (18) and at a similar distance to the LAA opening. Andthe implantation location can have various distances toward the LAAopening so long as the tissue anchors can achieve the intended closure.FIG. 11A illustrates another embodiment of the present teachings, whereone tissue anchor (40) is implanted at the deep end of the LAA chamber(8), and two tissue anchors (20, 30) are implanted inside the LAAchamber (8) and across the tissue wall near the opening. Each tissueanchor (20, 30, & 40) is attached with a tensioning member (24, 34,& 44)and all the three tensioning members (24, 34, & 44) extend proximallyfrom the respective tissue anchors (20, 30, & 40), across the leftatrium (6), and back outside the body, and the proximal ends of thetensioning members remain under the control of a clinician. Asillustrated in FIG. 11B, upon the clinician pulling on all threetensioning members (24, 34, & 44), the bottom of the LAA chamber (8)everts as the tissue anchor (40) at the deep end is drawn close to theother two tissue anchors (20, 30) near the opening of the LAA chamber(8). As all the three tissue anchors (20, 30, & 40) are drawn together,the LAA chamber (8) is effectively eliminated completely.

Although the embodiments in FIGS. 7 and 11 show three tissue anchors(20, 30, & 40) with a similar size are used to close and/or eliminatethe LAA chamber (8), one skilled in the art should understand that,tissue anchors with various sizes could be used for the closure.Additionally, although the embodiments in FIGS. 9-11 show that twoand/or three tissue anchors are used, one skilled in the art shouldunderstand that more or less than three tissue anchors could be used.

According to another aspect of the embodiments, tissue anchors of morethan one size are incorporated to close a LAA chamber (8). FIGS. 12A-12Billustrate another embodiment of the present teachings, where onesmaller tissue anchor (50) similar to what has been described in U.S.Pat. No. 8,945,211, filed on Sep. 11, 2009, entitled “TISSUE PLICATIONDEVICE AND METHOD OF ITS USE,” is implanted across the tissue inside theLAA chamber (8) near the opening, and a larger second tissue anchor (60)is implanted at a second chamber wall location further away from theopening. As shown in FIG. 12A, the second tissue anchor (60) has anenlarged distal portion placed against outside of the LAA chamber wall(18). The proximal portion of the second tissue anchor (60) is placedagainst the inner wall of the LAA chamber (8). The size of the proximalportion of the second tissue anchor (60) can be as big as or bigger thanits distal portion. The size of the proximal portion of the secondtissue anchor (60) can also be smaller than its distal portion, forexample, as illustrated in FIG. 12A. As the first and second tissueanchors (50, 60) are pulled together, the larger proximal portion of thesecond tissue anchor (60) pushes against the LAA chamber wall (18) andeffectively causes the wall to collapse toward the opposite wall of theLAA chamber (8), thereby reducing, closing, and/or eliminating the LAAchamber (8), as shown in FIG. 12B. Although FIGS. 12A-12B illustrate oneexemplary second tissue anchor, one skilled in the art should understandthat other tissue anchor designs can be used for this purpose, and thusspecific example disclosed herein should not be viewed as limiting tothe scope of the present teachings.

According to some embodiments of the present teachings, the LAA closuresystem can also be used in addition to other treatment mechanisms. Forexample, FIG. 13 illustrates another embodiment of the presentteachings, wherein a substantial portion of the LAA chamber (8) isfilled with a space filling material (100). The opening of the LAAchamber (8) is then closed off with multiple tissue anchors (20, 30)implanted across the LAA chamber wall (18) near its opening, drawn toone another, and locked in place with a lock member. According to someembodiments, the filling material (100) could be a solid, a liquid, agas, a foam, or a gel. The filling material (100) may include a salinesolution or silicone. The filling material (100) may include aradiopaque material. The filling material (100) may include at least onebio-inert material or biocompatible material. The filling material (100)may include a first reagent and a second reagent, the second reagentbeing functional to activate the first reagent. It should be understoodthat other filling material (100) known to those skilled in the artcould all be applicable here.

FIG. 14 illustrates another embodiment, where the LAA closure systemincludes a first relatively smaller tissue anchor (20) and a secondrelatively large plate shaped tissue anchor (70) deployed opposite ofthe first smaller tissue anchor (20). In one embodiment, the firstrelatively smaller tissue anchor (20) is similar to the anchorsdescribed herein. In another embodiment, the second relatively largertissue anchor (70) has a collapsed delivery profile and a radiallyexpanded deployed configuration. At its delivery profile, the secondtissue anchor (70) elongates and is housed inside the lumen of thetissue anchor delivery catheter (22). At its deployed profile, thesecond tissue anchor (70) expands radially and assumes a pre-definedopen umbrella or plate like shape. FIG. 14 illustrates a closure platepositioned against outside of the LAA chamber (8), located somewherehalf-way of the chamber length. Once the second tissue anchor (70) ispulled toward the first tissue anchor (20), the plate shape collapses agreater area of the LAA chamber wall (18) which ensures an enhancedclosure.

FIG. 15A-B illustrate some embodiments of second tissue anchor (70 a) asdescribed in FIG. 14, according to some embodiments of the presentteachings. FIG. 15A illustrates one embodiment, where the deployedsecond tissue anchor (70 a) is made of a continuous wire with spiralturns. The wire is straightened and housed inside the tissue anchordelivery catheter (22) during delivery. Once extending outside thecatheter, the wire resumes its pre-defined shape, such as the oneillustrated in FIG. 15A. FIG. 15B illustrates another embodiment, wherethe deployed second tissue anchor (70 b) is made of multiple strutsextending from a common center. The struts fold distally and radiallyinward while housed inside the tissue anchor delivery catheter (22)during delivery. Once the anchor extends outside of the catheter, thestruts expand radially forming a plate/disc profile such as the oneillustrated in FIG. 15b . FIGS. 15A-15B are two embodiments of thesecond large tissue anchor (70) as illustrated in FIG. 14. One skilledin the art should understand other tissue anchor designs could beadopted to achieve the same LAA closure purpose. Thus, the twoembodiments provided herein should not be viewed as limiting to thescope of the present teaching.

One skilled in the art should understand that the LAA closure systemdescribed herein can also be used in combination with other treatmentsystems. The examples described herein should not be viewed as limitingto the scope of the present teaching.

FIGS. 7-14 show that multiple tissue anchors, each of which connects toa tensioning member, and all the tensioning members are locked with alocker to secure the tensioned position among the anchors. One skilledin the art would understand that these tissue anchors can be connectedwith one tensioning member. In this case, by tensioning the onetensioning member, all three tissue anchors are drawn closer and the LAAis closed. FIGS. 16A-C illustrate another embodiment of the presentteachings, where multiple tissue anchors (80 a, 80 b) are joined withone tensioning member (84). For example, the catheter can have twolumens arranged side by side, one for the locating wire, and the otherfor the tissue anchor. The distal end of the catheter is actuated to bepositioned against the LAA chamber wall at a first location, so that thelumen of its distal portion is generally perpendicular to the tissue.The locating wire then pierces the tissue with its distal end crossingthe tissue and reaching the outside of the LAA. A first tissue anchor(80 a) follows the path created by the location wire, and deploys at thefirst location, as illustrated in FIG. 16A. Once the first tissue anchor(80 a) is satisfactorily deployed at the first location, the locatingwire is withdrawn proximally. The catheter is then actuated to bepositioned at a second location inside the LAA chamber (8). The abovedescribed steps then repeat so that a second tissue anchor (80 b) isimplanted at a second location as illustrated in FIG. 16B. FIG. 16Bfurther illustrates that all the tissue anchor (80 a, 80 b) aresatisfactorily deployed in place, one tensioning member (84) having itsdistal end abutting one side of the first tissue anchor (80 a),extending through the first tissue and anchor, continuing its waythrough the second tissue anchor (80 b). The remaining portion of thetensioning member (84) extends through the tissue anchor deliverycatheter (82) proximally to the outside of the body and remains underthe control of a clinician. Upon the clinician pulling the tensioningmember (24), the first tissue anchor (80 a) is drawn closer to thesecond tissue anchor (80 b) and the second tissue drawn closer to thethird tissue anchor (not shown). A lock member (86) then secures all thethree tissue anchors. As shown in FIG. 16C, the opening of the LAAchamber (8) is then closed. The multiple tissue anchors joined by onetensioning member also include those disclosed in U.S. patentapplication Ser. No. 14/662,203, filed on Mar. 18, 2015, entitled“TISSUE ANCHORS AND PERCUTANEOUS TRICUSPID VALVE REPAIR USING A TISSUEANCHOR,” the entirety of which is incorporated here by reference.

Various embodiments have been illustrated and described herein by way ofexamples, and one of ordinary skill in the art would recognize thatvariations can be made without departing from the spirit and scope ofthe present teachings. The present teachings are capable of otherembodiments or of being practiced or carried out in various other ways.Also, it is to be understood that the phraseology and terminologyemployed herein is for the purpose of description and should not beregarded as limiting.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this present teachings belong. Methods and materialssimilar or equivalent to those described herein can be used in thepractice or testing of the present teachings. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and notintended to be limiting.

We claim:
 1. A method for resizing left atrium appendage comprising,inserting a locating wire from right atrium, cross atrial septum, acrossleft atrium, and into a left atrial appendage (LAA) chamber, placing thelocating wire across a tissue wall at a first location inside the LAAchamber, implanting a first tissue anchor at the first location, placingthe locating wire across a tissue wall at a second location inside theLAA chamber, implanting a second tissue anchor at the second location,and pulling the first and second tissue anchors toward each other sothat the tissue wall at the first and second locations of the LAAchamber are pulled together.
 2. The method of claim 1, further includingthe steps of: placing the locating wire across the tissue wall at athird location approximate to a bottom of the LAA chamber, implanting athird tissue anchor at the third location, and pulling the first, secondand third tissue anchors toward each other so that the bottom of the LAAchamber is everted and tissue wall at the first, second and thirdlocations of the LAA chamber are pulled together.
 3. The method of claim1, wherein a distal end of the locating wire is configured to connect toan RF energy source.
 4. The method of claim 1, further including atissue anchor delivery catheter that tracks along the locating wire andis configured to deliver the first tissue anchor and the second tissueanchor.
 5. The method of claim 1, wherein each of the first tissueanchor and the second tissue anchor has a unitary construction definedby a plurality of folded panels, the tissue anchor being coupled to atensioning member that is threaded through the tissue anchor in a distaldirection and is threaded through the tissue anchor in a proximaldirection, the tissue anchor having a slip knot positioned such thatwhen a proximal end portion of the tensioning member is pulled, thetissue anchor is drawn together to form the plurality of panels alongpre-defined fold lines.
 6. The method of claim 5, wherein a proximal endportion of the tensioning member extends outside the body, thetensioning member and the locating wire being disposed within a lumen ofa common catheter.
 7. The method of claim 1, wherein each of the firstand second tissue anchors comprises a foldable anchor that has atensioning member extending along a length thereof and the step ofpulling the first and second tissue anchors toward each other comprisesthe step of pulling the tensioning members of the first and secondtissue anchors.
 8. The method of claim 7, further including a lockmember that is applied to the tensioning members of the first and secondtissue anchors.
 9. The method of claim 1, wherein the first tissueanchor has a size different than a size of the second tissue anchor. 10.The method of claim 1, wherein a proximal portion of the second tissueanchor is smaller than a distal portion thereof.
 11. The method of claim1, further including the step of prior to pulling the first and secondtissue anchors toward each other, injecting a space filling materialinto the LAA, wherein the space filling material is selected from agroup consisting of: a solid, a liquid, a gas, a foam, and a gel. 12.The method of claim 11, wherein the space filling material comprises afirst reagent and a second reagent, the second reagent being functionalto active the first reagent.
 13. The method of claim 1, wherein thesecond tissue anchor is delivered by a tissue anchor delivery catheterand has a collapsed delivery profile and a radially expanded deployedconfiguration, wherein in the collapsed delivery profile, the secondtissue anchor elongated and is housed inside a lumen of the tissueanchor delivery catheter and in the radially expanded deployedconfiguration, the second tissue anchor expands radially and assumes atleast one of an open umbrella shape and a plate shape.
 14. The method ofclaim 13, wherein second tissue anchor, in the radially expandeddeployed configuration, comprises a continuous wire with spiral turns.15. The method of claim 13, wherein second tissue anchor, in theradially expanded deployed configuration, comprises multiple strutsextending from a common center.
 16. The method of claim 1, wherein adistal end of the locating wire is positioned against the fossa ovalisand the locating wire is then advanced distally to pierce the atrialseptum at the fossa ovalis.
 17. The method of claim 1, wherein the firstlocation is near an opening of the LAA with a distal portion of thefirst tissue anchor is placed against an outside of the LAA chamber anda proximal portion of the first tissue anchor is placed against aninside of the LAA chamber and a tensioning member, that extends alongand passes through the first tissue anchor, extends proximally through alumen of a tissue anchor delivery catheter to an outside of a patient'sbody.
 18. The method of claim 1, further including a tissue anchordelivery catheter for delivering the first and second tissue anchors andas the locating wire retracts from the first location, the locating wiredisengages the tissue anchor delivery catheter and a distal end of thelocating wire remains inside the left atrium during deployment of thefirst tissue anchor using the tissue anchor delivery catheter.
 19. Amethod for resizing left atrium appendage comprising, implanting a firsttissue anchor at a first location across a tissue wall inside a LAAchamber, implanting a second tissue anchor at a second location across atissue wall inside the LAA chamber, wherein the first tissue anchor islarger than the second tissue anchor, and pulling the first and secondtissue anchors toward each other so that the LAA chamber collapses. 20.A method for resizing left atrium appendage comprising, implanting afirst tissue anchor at a first location across a tissue wall inside aLAA chamber, implanting a second tissue anchor at a second locationacross a tissue wall inside the LAA chamber, filling the LAA chamberwith a space filling material, and pulling the first and second tissueanchors toward each other so that the tissue wall at the first andsecond locations of the LAA chamber are pulled together and the spacefilling material is prevented from escaping the LAA chamber.
 21. Themethod of claim 20, wherein the space filling material is selected froma group consisting of: a solid, a liquid, a gas, a foam, and a gel. 22.The method of claim 20, wherein the space filling material comprises atleast one bio-inert material or biocompatible material.